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FDA 510(k)

Bone Solutions Mixing and Delivery System

K-Number: K161568 · 2016-09-16

ApplicantBone Solutions, Inc.
Decision Date2016-09-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bone Solutions Mixing and Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Bone Solutions, Inc.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K161568. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bone Solutions Mixing and Delivery System?

Bone Solutions Mixing and Delivery System is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Bone Solutions, Inc.. The 510(k) number is K161568.

When did Bone Solutions Mixing and Delivery System receive FDA 510(k) clearance?

Bone Solutions Mixing and Delivery System received FDA 510(k) clearance on 2016-09-16, under 510(k) number K161568.

Who is the listed applicant for Bone Solutions Mixing and Delivery System?

The FDA 510(k) record lists Bone Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Solutions Mixing and Delivery System?

The FDA product code for Bone Solutions Mixing and Delivery System is FMF.

Other records listing Bone Solutions, Inc. as applicant

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Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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